JAC Advance Access originally published online on June 11, 2007
Journal of Antimicrobial Chemotherapy 2007 60(2):356-362; doi:10.1093/jac/dkm210
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Outpatient parenteral antimicrobial therapy (OPAT): is it safe for selected patients to self-administer at home? A retrospective analysis of a large cohort over 13 years
1 Oxford Radcliffe Hospitals NHS Trust, John Radcliffe Hospital, Headley Way, Oxford OX3 9DU, UK 2 Bone Infection Unit, Nuffield Orthopaedic Centre NHS Trust, Windmill Road, Headington, Oxford OX3 7LD, UK 3 The Pavilion, Thames Road, Goring on Thames, Reading, Berkshire RG8 9AH, UK 4 Oxfordshire Primary Care Trust, Unit 1, Isis Business Park, Pony Road, Oxford OX4 2RD, UK
* Corresponding author. Tel: +44-1865-738029; Fax: +44-1865-227694; E-mail: p.matthews{at}doctors.org.uk
Received 19 February 2007; returned 10 April 2007; revised 16 May 2007; accepted 17 May 2007
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Abstract |
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Objectives: Provision of outpatient parenteral antimicrobial therapy (OPAT) is an evolving field, facilitating discharge from hospital for selected patients with serious infections. We report on a large OPAT cohort focusing on the practice of supervised parenteral antibiotic administration in the community by patients and relatives, which we collectively term ‘self-administration’. To distinguish between healthcare professional OPAT and self-administered OPAT, we have coined the terms H-OPAT and S-OPAT, respectively.
Patients and methods: We analysed data on 2059 OPAT episodes collected prospectively over a 13 year time period from 1993 to 2005.
Results: Clinical diagnosis, microbiology and antibiotics in this OPAT series are comparable to those previously reported. We identified no excess complications or hospital re-admissions in the S-OPAT group compared with the H-OPAT group.
Conclusions: Self-administration of intravenous antimicrobial therapy, in selected patients under the supervision of a specialist team, is a safe and feasible strategy.
Keywords: home intravenous therapy , H-OPAT , S-OPAT , self-administration , complications
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Introduction |
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Outpatient parenteral antimicrobial therapy (OPAT) is increasingly used to facilitate early discharge from hospital and is evolving in parallel with the availability of appropriate once-daily antibiotics, improved vascular access devices and provision of specialist services.1 Previously published data substantiate advantages to hospitals, clinicians and patients,2,3 pointing to a significant improvement in physical, social and emotional quality of life parameters associated with discharge into an OPAT programme.4,5
OPAT services require a coordinated multidisciplinary approach.1,3 In the UK, programmes traditionally rely upon recruitment of healthcare workers in the community to administer antibiotics,6 constituting healthcare professional OPAT (which we term H-OPAT). However, H-OPAT provision varies between different parts of the UK and is unavailable in some countries. Early discharge from hospital may then be dependent on teaching the patient, a relative or carer to administer therapy.
Oxford's OPAT service was established in 1993,3,7 and is now one of the largest in the UK, with an annual caseload of over 250 in 2005. In this and other series, musculoskeletal infection is the largest diagnostic group,1,2,5,8 and Gram-positive organisms are the most common agents of infection.8–10 A variety of vascular access devices is used, most commonly a Peripherally Inserted Central Catheter (PICC).11
Since the conception of OPAT services in the 1970s, self-administration has been described as a delivery model,5,9,12–17 but many of the published series are relatively small. Here, we have classified a cohort of over 2000 patients into those having OPAT administered by H-OPAT and those self-administering (S-OPAT), which includes the patient, relative or carer. Concern about potential complications may be a barrier to widespread implementation of S-OPAT. We therefore evaluated whether, correctly supervised, it is a safe and practical service.
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Patients and methods |
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Data collection
We carried out a retrospective analysis of all OPAT patient episodes managed by Oxfordshire Primary Care Trust Home IV Team over a 13 year time period. Data were collected prospectively between 1 January 1993 and 31 December 2005 and were recorded on a Microsoft Access database by Clinical Nurse Specialists according to clinical diagnoses ascertained by clinicians, with laboratory data provided by Oxford Radcliffe Hospitals microbiology department.
Structure and organization of the OPAT service
Our specialist OPAT team of Clinical Nurse Specialists and Infectious Diseases physicians accepts referrals from Nuffield Orthopaedic Centre NHS Trust, Oxford Radcliffe Hospitals NHS Trust and Oxfordshire Primary Care Trust. The majority of referrals originate from the Bone Infection Unit at the Nuffield Orthopaedic Centre, a specialist tertiary referral unit managing bone and joint infection. Vascular access devices are inserted by Clinical Nurse Specialists or by the radiology department.
Patient selection and contract of care
Patients referred to the service are assessed by a Clinical Nurse Specialist to ensure they are fit for discharge and have an appropriate discharge destination. Patients are eligible for self-administration if they do not live alone, have intact eyesight and sufficient dexterity to handle an intravenous access device and are medically and psychologically stable with normal cognitive function. All patients receive at least two doses of the antimicrobial agent before discharge.
S-OPAT patients receive intensive supervision and training before leaving hospital (including instruction in drug storage, re-constitution and administration, and education about care of the vascular access device). A competency assessment is undertaken and signed by the patient and a Clinical Nurse Specialist, and patients are provided with written details about their management. Patients failing the competency assessment may be deferred and offered further training and a repeat assessment, or may be considered unsuitable for S-OPAT and offered alternative treatment. A visit is made to supervise the first antibiotic dose at home for S-OPAT patients. Review of all OPAT patients is undertaken on a weekly basis to check routine blood tests, change line dressings and bungs and provide medical assessment when required. A 24 h telephone support service with named consultant physician cover is also provided.
Ethics approval was not required for this study.
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Results |
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We recorded 2059 consecutive OPAT episodes over 13 years. Data collection at the outset of the study was limited, but detailed data were available for 2009 patient episodes (97.6% of the total cohort). We therefore report our results with a denominator of either 2059 or 2009.
The number of OPAT episodes increased on an annual basis from 38 in 1993 to 286 in 2005. Overall, 473 of 2009 (24%) patients who were discharged to the community self-administered all or part of their parenteral therapy and are classified as S-OPAT episodes. The number of S-OPAT patients increased from 14 patients in 1993 to 110 in 2005 (from a nadir of 12% of the total in 1997 to over 30% from 2002 onwards). Within the S-OPAT group, 88 patients (20%) had a partner, carer or other family member trained to administer therapy.
Of 2009 patients, 1285 (64%), were male, with this gender excess increasing to 73% in the S-OPAT group. Age data were available for 1966 patients, mean 60.9 years for H-OPAT patients and 46.2 for S-OPAT patients. Paediatric referrals (age < 16) are usually managed by specialist children's services and accounted for only 0.3% of this series. During the period studied, 136 patients had more than one treatment episode recorded. The mode of the duration of parenteral therapy was 6 weeks; this was the completed duration in 60% and 63% of H-OPAT and S-OPAT episodes, respectively.
Clinical and laboratory diagnosis
In total, 2134 clinical diagnoses were recorded for 2059 patient episodes (Table 1). Musculoskeletal infections accounted for 78% of all diagnoses in the H-OPAT group and 84% in S-OPAT patients. Microbiology data were available for 2009 episodes (Table 2). A total of 2329 aetiological diagnoses were made. Staphylococcus aureus (of which 32% were methicillin resistant) accounted for 35% of infections and coagulase-negative staphylococci for 19%. Samples taken from 170 H-OPAT patients and 55 S-OPAT patients were culture negative; these patients had a diagnosis made on clinical and/or histopathological grounds and were treated empirically.
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Choice of parenteral antibiotics and vascular access devices
We recorded 2208 episodes of antimicrobial treatment in 2059 patients (Table 3). ß-Lactams and glycopeptides were the most common antibiotics used, accounting for 53% and 43% respectively, with no difference between frequency of prescription in H-OPAT and S-OPAT groups. The most frequently prescribed agents were ceftriaxone (used in 49% of H-OPAT episodes and 32% of S-OPAT) and teicoplanin (used in 39% and 33%, respectively).
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Vascular access data were recorded for 2770 episodes in 2059 patients (Table 4). A PICC was used in 64% of H-OPAT and 71% of S-OPAT episodes. Dates of insertion and removal were available for 2636 lines, which were in situ for a mean of 35 days per line in H-OPAT patients and 34 days per line in S-OPAT patients.
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Patient location
Of 2009 patient episodes, 1862 (93%) were discharged to a private address, of which 1846 (99%) were resident at their own home. The remainder was discharged to community hospitals, nursing homes, rehabilitation units and one patient to prison. Healthcare professionals involved in H-OPAT were predominantly community nurses or community hospital staff.
Complications and re-admission to hospital
Complications included events both related and unrelated to the OPAT programme (Figure 1 and Table 5). In total, 476 of 2009 (24%) patients had any complication recorded. Nearly one-third (31%) of complications were unrelated to OPAT, but either related to the original diagnosis or reflected the development of a new problem.
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Side effects or intolerance of drugs accounted for the majority of complications (affecting 12% of both H-OPAT and S-OPAT patient groups). Complications pertaining to the vascular access device affected 0.5% of all H-OPAT patients and 1% of S-OPAT patients, but this difference is not statistically significant (P = 0.2, Fisher's exact test). We are unable to calculate the precise number of complications per line-day in this cohort, but can estimate complication rates (based on average number of line-days per treatment episode): 14 line-related complications approximate to 0.2 complications per 1000 line-days and 253 drug-associated complications to 3.8 complications per 1000 line-days (Table 5).
Overall, the complication rate for S-OPAT was 24% (112 of 473 episodes) compared with 23% for H-OPAT (353 of 1536 episodes), indicating no excess complication risk for the self-administering group in this cohort (P = 0.7, Fisher's exact test).
Re-admission to hospital occurred in 247 patients, of which 193 were in the H-OPAT group and 50 in the S-OPAT group (re-admission rates of 12.6% and 10.5% respectively, P = 0.3, Fisher's exact test). Only one S-OPAT patient was re-admitted because of failure to cope and one H-OPAT patient due to problems with logistical arrangements. Two patients in the programme (neither self-administering) died, both from cardiac causes unrelated to OPAT.
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Discussion |
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Provision of OPAT is evolving with the potential for optimizing standards of patient care, improving patient satisfaction and reducing costs. Prolonged intravenous antibiotics are the standard of care for many musculoskeletal infections especially those involving spine, osteomyelitis without ablative surgery and prosthetic joint infections managed with debridement and retention or two stage revision.18–20 We discuss the potential role of non-healthcare professionals in administration of parenteral therapy.
Patient characteristics and diagnosis
Our S-OPAT patients were younger, more likely to be male and more likely to have a PICC line than patients in the H-OPAT group. Mean duration of OPAT in our cohort is comparable to previously reported data,5 and, as in other series, soft tissue infections and osteomyelitis predominate.2,6,21–23 Microbiology is dominated by Gram-positive pathogens, and the rate of methicillin resistance in S. aureus reflects trends reported by other local and national surveillance data.24,25
Choice of parenteral antibiotics and vascular access devices
Ceftriaxone and glycopeptides are our most commonly prescribed antibiotic agents due to advantageous spectrum of action, cost, tolerability and pharmacokinetic profiles.5,26,27 The PICC is a favoured route of vascular access, being cost effective, easy to insert and remove and associated with complication rates similar to other devices.28–30
The requirement for early hospital discharge has promoted self-administration. Recent guidelines do not specifically discuss antibiotic self-administration, but the roles and responsibilities of patients and caregivers are highlighted.1 Patient selection for OPAT programmes, including self-administration, must be stringent: patients must be willing and motivated, medically and psychologically stable, and have plans for discharge to a suitable environment.1,4,5,31,32 Responsible provision of OPAT services demands rigorous patient selection, detailed training of participants, regular outpatient review and provision of 24 h support.3 As well as satisfying a demand for community care and reducing the workload of healthcare professionals, S-OPAT empowers patients and increases patient autonomy and satisfaction.7,33
The reasons for the male excess in our S-OPAT group are uncertain. We postulate that healthy young men may be over-represented in the osteomyelitis group (due to excess involvement in trauma), that men may find self-administration techniques easier to learn or more acceptable than women, or that an unconscious gender bias on the part of staff means that more male patients are offered S-OPAT. The mean age of H-OPAT patients was greater than S-OPAT, reflecting the needs of elderly patients, who are less likely to meet eligibility criteria for self-administration.
Complications, re-admission to hospital and adherence to therapy
In this cohort, 31% of complications were unrelated to the antimicrobial treatment or intravenous access device, comparing favourably with other OPAT series.2,9,10 Complications related to the vascular access device are relatively uncommon in previous cohorts;22,34,35 quantified at 1.5 per 1000 catheter days.29 Likewise, mechanical catheter dysfunction and infectious complications of vascular access devices are infrequent problems in our series. However, line infections may be more frequent in programmes without stringent supervision, and we stress the need for rigorous training and support to avoid this complication.
We are not aware of any published data describing adherence patterns of patients in OPAT programmes, but suggest that compliance with therapy in our S-OPAT group is likely to be equivalent to H-OPAT, based firstly on careful patient selection and education and secondly on the regular follow-up contact this group receives. This study does not extend to follow-up to determine treatment outcomes and we are unable to comment specifically on cure rates.
Expenditure associated with OPAT services (provision of specialist staff, equipment and drugs)5 is generally offset by the costs saved by discharge from hospital.13,21,36 In the last calendar year of our study, 286 patients were discharged into the OPAT programme, estimated to save over 6200 bed-days. The comparable rate of complications and re-admissions, irrespective of antibiotic administrator, suggests that there is no ‘hidden’ cost incurred by complications in carefully selected S-OPAT patients.
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Conclusions |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsExternal fundingTransparency declarationsReferences |
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This large UK cohort is comparable to other published series, although our analysis is limited in some areas by missing data. We suggest the terms S-OPAT and H-OPAT could be useful in future to distinguish between self-administered and healthcare professional administered OPAT. Our evaluation of the extension of routine OPAT practice to include rigorously supervised self-administration in selected patients finds no evidence that this confers additional risk. These data empower clinical teams and patients to plan OPAT, with the reassurance that supervised administration by the carefully trained patient or carer is safe and practical.
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External funding |
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- The electronic database was originally set up with an unrestricted educational grant from Hoechst Marion Roussel.
- Interrogation of the database by Jill Willison was funded by the Bone Infection Education and Research Fund, part of the Nuffield Orthopaedic Centre Charitable Funds, a registered charity.
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Transparency declarations |
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TopAbstractIntroductionPatients and methodsResultsDiscussionConclusionsExternal fundingTransparency declarationsReferences |
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C. P. C. has served on advisory boards for Roche and Merck. A. R. B. has served on advisory boards and speakers bureaux for Pfizer and Merck.
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Acknowledgements |
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We are grateful to Jill Willison for her dedicated work on database management and analysis.
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References |
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  P. R. Ingram, Z. Sulaiman, A. Chua, and D. A. Fisher Comment on: Outpatient parenteral antibiotic therapy (OPAT): is it safe for selected patients to self-administer at home? A retrospective analysis of a large cohort over 13 years J. Antimicrob. Chemother., January 1, 2008; 61(1): 226 - 227. [Full Text] [PDF]
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